Label: ONLY FOR HEADACHE- acetaminophen, caffeine tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 73006-110-41 - Packager: O4 Global Trading Usa, Llc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated May 9, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DRUG FACTS
- Active ingredient (in each caplet)
- Purpose
- Uses:
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Warnings:
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 6 caplets in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Allergy alert:
Acetaminophen may cause severe skin reactions. Symptoms may include:
• skin reddening • blisters • rash
If a skin reaction occurs, stop use and seek medical help right away.
Caffeine warning:
The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally rapid heart beat.
Do not use
- if you are allergic to acetaminophen
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
- for more than 10 days for pain unless directed by a doctor
- for more than 3 days for fever unless directed by a doctor
Ask a doctor before use if
you have liver disease
Ask a doctor or pharmacist before use if,
you are taking the blood thinning drug warfarin
Stop use and ask a doctor if
• any new symptoms occur • pain gets worse or lasts for more than 10 days
• fever gets worse or lasts for more than 3 days
These could be signs of a serious condition
If pregnant or breast-feeding,
ask a health professional before use.
- Directions:
- Other Information:
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Inactive Ingredients:
colloidal silicon dioxide, croscarmellose sodium, D&C red #27 aluminum lake, FD&C yellow #6 aluminum lake, gelatin, magnesium stearate, maize starch, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, purified water, sodium starch glycolate, talc, titanium dioxide.
- Questions Or Comments ?
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SPL UNCLASSIFIED SECTION
NDC: 73006-110-41
ADULT
ANALGESIC(PAIN RELIEVER)
Distributed By: O4 GLOBAL TRADING USA LLC., 2241 S Watson RD, Suite 121 Arlington, TX 76010.
www.onlyfor.com
Packaged By: Strive Pharmaceuticals Inc., East Brunswick, NJ 08816.
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF A BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING.
Tear along perforation push product through foil - Packaging
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INGREDIENTS AND APPEARANCE
ONLY FOR HEADACHE
acetaminophen, caffeine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73006-110 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) MAGNESIUM PALMITOSTEARATE (UNII: R4OXA9G5BV) STARCH, CORN (UNII: O8232NY3SJ) MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POLYVINYL ALCOHOL (94000 MW) (UNII: C1MS7RRZ6L) WATER (UNII: 059QF0KO0R) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color red Score no score Shape OVAL (Caplet) Size 18mm Flavor Imprint Code S777 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73006-110-41 1 in 1 CARTON 03/29/2019 1 4 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 03/29/2019 Labeler - O4 Global Trading Usa, Llc (081226861)
